MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ACTIS COLLARED HIGH SIZE 10; HIP FEMORAL STEM

Model Number	1010-12-100
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Codes	Fall (1848); Bone Fracture(s) (1870); Inadequate Osseointegration (2646); No Code Available (3191)
Date of Event	08/26/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
It was reported that patient fell a few weeks after surgery and fractured his femur.Femoral stem was removed, femur prepped for longer stem and cabled.Liner and head ball also replaced.It was also reported that the stem was loose at bone to implant interface.Doi: (b)(6) 2020.Dor: (b)(6) 2020.Affected side: right hip.
Additional Manufacturer Narrative
Product complaint#: (b)(4).Investigation summary: no device associated with this report was received for examination.Examination of a provided x-ray image confirms fracture of the femoral bone laterally just above the distal tip of the stem.The root cause is attributed to the patient sustaining a fall.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed, and the investigation will be re-opened as necessary.

• Brand Name: ACTIS COLLARED HIGH SIZE 10
• Common Device Name: HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 10522217
• Report Number: 1818910-2020-19878
• Device Sequence Number: 3118113
• Product Code: KWL
• UDI-Device Identifier: 10603295380627
• UDI-Public: 10603295380627
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K160907
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 1010-12-100
• Device Catalogue Number: 101012100
• Device Lot Number: HU8756
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/26/2020
• Supplement Date Received by Manufacturer: 10/15/2020
• Initial Report FDA Received Date: 09/11/2020
• Supplement Report FDA Received Date: 10/16/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: BI MENTUM PFRK PE LINER 28 55; CONTROL CABLE W/CABLE SLEEVE; DELTA CER HEAD 12/14 28MM +5; BI MENTUM PFRK PE LINER 28 55; CONTROL CABLE W/CABLE SLEEVE; DELTA CER HEAD 12/14 28MM +5
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 68 YR
• Patient Weight: 106